SBIR Phase I: Development of a Novel, Sprayable, Large Volume Hydrogel Delivery System Platform

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是一个简化的系统，用于在外科手术过程中原位应用化合物形成生物材料。受控生物材料的应用具有显著的潜在外科优势，包括抗粘连、组织密封剂和药物输送目的。拟议的平台将使程序一致性能够提供新的和改进的方法来控制手术过程中的出血和减少疤痕组织的形成。该产品旨在获得15亿美元的粘连预防市场和12亿美元的止血器市场的份额，并最终实现特定部位的输送细胞和药物，具体取决于输送的生物材料。这个小型企业创新研究(SBIR)第一阶段项目将为原位成型生物材料开发一种即用即用的大容量输送系统。活动范围包括将一种新型的、专有的、可用作组织密封剂、疤痕组织减少剂和药物/细胞输送载体的原位生物材料转移到一种新型的一次性涂抹器中。预包装递送系统将使用内部机械机构将悬浮生物材料与再悬浮溶液配制在一起，该内部机械机构以适合临床使用的受控雾化方式递送生物材料。这一阶段的项目旨在在良好的制造实践中完成和验证冷冻干燥生物材料的原型，设计注射器桶和输送尖端/喷嘴的设计，并以适合人类首次使用的方式完成实验室验证。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a simplified system for applying compound in situ to form biomaterials during surgical procedures. Controlled biomaterial applications pose significant potential surgical advantages including for anti-adhesion, tissue sealant, and drug delivery purposes. The proposed platform will enable procedural consistency to provide new and improved ways to manage bleeding and reduce scar tissue formation during surgical procedures. This product aims to gain a share of the $1.5 billion adhesion prevention market and $1.2 billion hemostat market, and enable eventual site-specific delivery cells and drugs, depending on the biomaterial delivered. This Small Business Innovation Research (SBIR) Phase I project will develop a ready-to-use, large volume delivery system for in situ forming biomaterials. The scope of activities includes transferring a novel, proprietary, in situ biomaterial with applicability as a tissue sealant, scar tissue reductant, and drug/cell delivery vehicle, into a novel single use applicator. The prepackaged delivery system will formulate the suspended biomaterial with the resuspension solution using an internal mechanical mechanism which delivers the biomaterial in a controlled aerosolized manner suitable for clinical use. This Phase 1 project aims to complete and validate prototypes with lyophilized biomaterials within good manufacturing practices, engineer the design of the syringe barrel and delivery tips/nozzles, and complete laboratory validation in a manner suitable for first in human use.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.